Objective: To examine the use of oral/transdermal anti-parkinsonian medications in advanced Parkinson’s disease (APD) patients who have a history of or current treatment with deep brain stimulation (DBS), and are receiving levodopa-carbidopa intestinal gel (LCIG).
Background: As PD progresses, oral drug regimens may become inadequate for symptom control. Patients using DBS with adjunctive oral therapy may continue to experience motor fluctuations requiring additional therapies like LCIG, known as CLES in the United States.
Design/Methods: PD-DUAL is a multicenter, retrospective chart review of APD patients with DBS and subsequent treatment with LCIG in the United States. APD patients with a history of DBS and ≥2 recorded visits before LCIG initiation and 2 visits (6 months) follow-up after LCIG initiation were included. The primary endpoint is the mean decrease of oral levodopa-equivalent daily dosage (LEDD) during a 16-hour waking day after LCIG initiation from baseline to 6 months. Secondary endpoints include percentage of individuals with reductions from baseline in total oral levodopa daily dose after LCIG initiation, latency from LCIG initiation until introduction/tapering of each PD medication, and the percentage of patients treated with DBS and LCIG for whom LCIG is a monotherapy.
Results: As of 10 July 2020, 34 patient records were evaluable. The mean age is 67 years and 73% are male. Of 34 patients, 31 (91.2%) were taking levodopa-containing medications and 25 (73.5%) were taking non levodopa-containing anti-PD medications. For the primary endpoint, 20 patients had >75% reduction (10 patients with 100% reduction); 5 had >50% to ≤75% reduction; and 3 had 0 to ≤25% reduction. Two patients had no medication at baseline, and one had no reduction.
Conclusions: Interim results demonstrated a median reduction of oral/transdermal LEDD (92%) 6 months post LCIG initiation in APD patients with a history of or current treatment with DBS.